`
`IPR2020-00314
`U.S. Patent 9,856,287
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`FRESENIUS KABI USA, LLC AND FRESENIUS KABI SWISSSBIOSIM
`GmbH.,
`Petitioners
`
`v.
`AMGEN INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owners
`______________________
`Case IPR2020-00314
`Patent 9,856,287
`______________________
`
`
`
`PATENT OWNERS’ PRELIMINARY RESPONSE
`UNDER 37 C.F.R. §42.107
`
`
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`

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`
`
`Exhibit
`EX2001
`EX2002
`EX2003
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`EX2004
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`EX2005
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`EX2006
`EX2007
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`EX2008
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`EX2009
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`EX2010
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`EX2011
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`EX2012
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`EX2013
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`EX2014
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`IPR2020-00314
`U.S. Patent 9,856,287
`
`LIST OF EXHIBITS1
`
`
`Description
`Prosecution History of U.S. Patent 9,856,287
`Declaration of Sayem Osman
`Excerpt of Joint Claim Construction Chart (Amgen Inc., et al. v.
`Kashiv Biosciences, LLC, No 2:18-cv-03347-CCC-MF, DE 101, at
`Appx. D (D.N.J. March 22, 2019))
`Fresenius Kabi USA, LLC et al. v. Amgen Inc. et al., IPR2019-
`00971, EX3001 (Dec. 27, 2019)
`Fresenius Kabi USA, LLC et al. v. Amgen Inc. et al., IPR2019-
`00971, EX3002 (Dec. 27, 2019)
`Declaration of Megan Raymond
`Adello Biologics, LLC et al. v. Amgen Inc. et al., PGR2019-00001,
`Docket Sheet
`Excerpt of Adello Biologics, LLC et al. v. Amgen Inc. et al.,
`PGR2019-00001, Pap. 8 (Jan. 23, 2019)
`Fresenius Kabi USA, LLC et al. v. Amgen, Inc., IPR2019-00971,
`Docket Sheet
`Fresenius Kabi USA, LLC et al. v. Amgen, Inc., IPR2019-00971,
`Pap. 17 (Dec. 4, 2019)
`Excerpt of Fresenius Kabi USA, LLC et al. v. Amgen, Inc.,
`IPR2019-00971, Pap. 8 (July 17, 2019)
`Excerpt of Fresenius Kabi USA, LLC et al. v. Amgen, Inc.,
`IPR2019-00971, Pap. 12 (Sept. 5, 2019)
`Excerpt of Adello Biologics, LLC et al. v. Amgen Inc. et al.,
`PGR2019-00001, Pap. 3 (Oct. 1, 2018)
`Excerpt of Adello Biologics, LLC et al. v. Amgen Inc. et al.,
`PGR2019-00001, EX1002 (Oct. 1, 2018)
`
`
`
` 1
`
` EX2008 and EX2011-EX2015 are included for comparison purposes to show
`
`overlap between proceedings and/or availability of information to the Petitioners.
`
`They are not submitted as substantive evidence.
`
`i
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`

`

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`
`
`Exhibit
`EX2015
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`
`
`IPR2020-00314
`U.S. Patent 9,856,287
`
`Description
`Excerpt of Adello Biologics, LLC et al v. Amgen Inc. et al,
`PGR2019-00001, Pap. 19 (July 26, 2018)
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`ii
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`TABLE OF CONTENTS
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`
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`IPR2020-00314
`U.S. Patent 9,856,287
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`
`I.
`II.
`
`2.
`
`3.
`
`Page
`Introduction .................................................................................................... 2
`The Challenged Claims Of The ’287 Are Directed To A Novel
`Invention ......................................................................................................... 7
`III. The Board Should Exercise Its Discretion And Deny Institution
`Under 35 U.S.C. §314(a) ................................................................................ 8
`A.
`The General Plastic Factors Support Denial Of Institution ......... 11
`1.
`Factor 1: Whether Petitioner Previously Filed A
`Petition Directed To The Same Claims Of The Same
`Patent ........................................................................................ 12
`Factor 2: Whether At The Time Of Filing Of The
`First Petition The Petitioner Knew Of The Prior Art
`Asserted In The Second Petition Or Should Have
`Known About It ....................................................................... 18
`Factor 3: Whether At The Time Of Filing Of The
`Second Petition The Petitioner Already Received The
`Patent Owner’s Preliminary Response To The First
`Petition Or Received The Board’s Decision On
`Whether To Institute Review In The First Petition ............. 19
`Factor 4: The Length Of Time That Elapsed Between
`The Time The Petitioner Learned Of The Prior Art
`Asserted In The Second Petition And The Filing Of
`The Second Petition ................................................................ 24
`Factor 5: Whether The Petitioner Provides Adequate
`Explanation For The Time Elapsed Between The
`Filings Of Multiple Petitions Directed To The Same
`Claims Of The Same Patent ................................................... 25
`Factors 6 and 7: Board’s Considerations Of Finite
`Resources/One-Year Time Line ............................................ 27
`Additional Factors Warrant Denial ...................................... 29
`7.
`IV. Petitioners Failed To Provide Sufficient Claim Construction
`Analysis Of Key Claim Terms .................................................................... 30
`
`4.
`
`5.
`
`6.
`
`iii
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`IPR2020-00314
`U.S. Patent 9,856,287
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`
`
`V.
`
`2.
`
`3.
`
`The Petition Failed To Establish Anticipation Or Obviousness Of
`Any Challenged Claim ................................................................................ 37
`A.
`Petitioners Failed To Show That Claims 1, 4, 8–10, 12, 14–
`16, 19, 23–26, And 20–30 Are Anticipated By Vallejo
`(Ground 1) .......................................................................................... 38
`1.
`Petitioners Failed To Show Vallejo Teaches The
`Limitation “Thiol-Pair Buffer Strength To Maintain
`The Solubility Of The Preparation/Solution” ...................... 38
`Petitioners Improperly Mix And Match Disclosures
`From Different Embodiments ................................................ 41
`Petitioners Failed To Present Any Argument
`Applying Their Assumed Construction Of “Is
`Calculated” And Cited To Art Other Than Vallejo In
`Arguing “Anticipation” .......................................................... 43
`Petitioners Failed To Establish That Claims 16, 19–21, 23–
`26, And 29–30 Are Anticipated By Ruddon (Ground 2) ............... 45
`1.
`Petitioners Failed To Show Ruddon Discloses A
`Process That Properly Refolds Proteins Into
`Biologically Active Forms ....................................................... 45
`Petitioners Failed To Show Ruddon Teaches The
`Limitation “Thiol-Pair Buffer Strength To Maintain
`The Solubility Of The Solution” ............................................ 46
`Petitioners Failed To Present Any Argument
`Applying Their Assumed Construction Of “Is
`Calculated” And Cited To Art Other Than Ruddon
`In Arguing “Anticipation” (Claims 23–25 And 30) ............ 47
`Petitioners’ Obviousness Grounds Are Unclear, Confusing,
`and Legally Insufficient (Grounds 3 And 4) ................................... 48
`1.
`Grounds 3 And 4 Are A Combination Of Multiple
`Poorly-Delineated Grounds.................................................... 51
`Petitioners Did Not Clearly Identify Which “Gilbert”
`Reference Was Intended To Be Part Of Grounds 3
`And 4 ........................................................................................ 53
`
`B.
`
`C.
`
`2.
`
`3.
`
`2.
`
`iv
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`3.
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`
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`IPR2020-00314
`U.S. Patent 9,856,287
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`Petitioners Did Not Clearly Identify The Base
`Reference For Ground 3 And Failed To Explain The
`Modifications To The Base Reference For Grounds 3
`And 4 Or Analyze The Motivation To Combine.................. 54
`Petitioners Failed To Articulate A Reasonable
`Expectation Of Success For Grounds 3 And 4 ..................... 59
`Petitioners Failed To Present Any Argument
`Applying Their Assumed Construction Of “Is
`Calculated” .............................................................................. 60
`VI. Conclusion .................................................................................................... 61
`
`
`
`4.
`
`5.
`
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`IPR2020-00314
`U.S. Patent 9,856,287
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`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`10X Genomics, Inc. v. Bio-Rad Labs., Inc.,
`IPR2018-00301, Pap. 18 (June 15, 2018) ........................................................... 60
`Abiomed Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Pap. 7 (April 16, 2018) ...................................................... 15, 19
`Adidas AG v. Nike, Inc.,
`IPR2016-00920, Pap. 6 (Oct. 20, 2016) ....................................................... 56, 57
`ADT LLC v. Applied Capital, Inc.,
`IPR2017-01825, Pap. 7 (Jan. 24, 2018) .............................................................. 57
`Am. Honda Motor Co. v. Intellectual Ventures II LLC,
`IPR2018-00347, Pap. 10 (June 27, 2018) ..................................................... 23, 29
`Amgen Inc. v. F. Hoffman-La Roche Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) .......................................................................... 60
`AOL Inc. v. Coho Licensing LLC,
`IPR2014-00966, Pap. 6 (Nov. 20, 2014) ............................................................ 51
`Apple, Inc. v. ContentGuard Holdings, Inc.,
`IPR2015-00358, Pap. 9 (July 2, 2015) ................................................... 51, 54, 58
`Apple Inc. v. Memory Integrity, LLC,
`IPR2015-00159, Pap. 12 (May 11, 2015) ........................................................... 60
`Apple Inc. v. Qualcomm Inc.,
`IPR2019-00112, Pap. 7 (Apr. 11, 2019) ............................................................. 17
`Axon Enter., Inc. v. Digital Ally, Inc.,
`IPR2017-00515, Pap. 10 (July 6, 2016) ............................................................. 57
`CareFusion Corp. v. Baxter Int’l, Inc.,
`IPR2016-01456, Pap. 9 (Feb. 6, 2017) ............................................................... 34
`
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`U.S. Patent 9,856,287
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`
`Chevron Oronite Co. v. Infieum USA LP,
`IPR2018-00923, Pap. 9 (Nov. 7, 2018) .......................................................... 6, 38
`Choirock Contents Factory Co. v. Spin Master Ltd.,
`IPR2019-00897, Pap. 17, (Sept. 26, 2019) ......................................................... 17
`Clim-A-Tech Indus., Inc. v. Ebert,
`IPR2017-01863, Pap. 13 (Feb. 12, 2018) ..................................................... 50, 55
`Cook Inc. v. Medtronic, Inc.,
`IPR2019-00123, Pap. 11 (June 11, 2019) ........................................................... 17
`Corning Optical Comm. RF, LLC, v. PPC Broadband, Inc.,
`IPR2014-00440, IPR2014-00041, and IPR2014-00736, Pap. 68
`(Aug. 18, 2015) ................................................................................................... 14
`Costco Wholesale Corp. v. Robert Bosch LLC,
`IPR2016-00035, Pap. 23 (Aug. 12, 2016) .......................................................... 41
`Costco Wholesale Corp. v. Robert Bosch LLC,
`IPR2016-00042, Pap. 28 (July 7, 2016) ............................................................. 55
`Crown Operations Int’l, Ltd. v. Solutia Inc.,
`289 F.3d 1367 (Fed. Cir. 2002) .......................................................................... 39
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 8
`Deeper, UAB v. Vexilar, Inc.,
`IPR2018-01310, Pap. 7 (Jan. 24, 2019) .......................................................... 7, 38
`DISH Network Corp. v. Customedia Techs., LLC,
`IPR2017-00936, Pap. 13 (Aug. 24, 2017) .......................................................... 55
`Dominion Dealer Sols., LLC v. Autoalert, Inc.,
`IPR2013-00225, Pap. 15 (Oct. 10, 2013) ........................................................... 57
`Dr. Reddy’s Labs., Inc. v. Celgene Corp.,
`IPR2018-01507, Pap. 7 (Feb. 11, 2019) ............................................................. 49
`
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`
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`Endo Pharm. Inc. v. Depomed, Inc.,
`IPR2014-00653, Pap. 12 (Sept. 29, 2014) .......................................................... 37
`Dep’t of Justice v. EnvisionIt, LLC,
`IPR2017-00186, Pap. 8 (May 3, 2017) ............................................................... 56
`Everstar Merchandise Co. v. Willis Elec. Co.,
`IPR2019-01484, Pap. 7 (Feb. 20, 2020) ............................................................... 6
`Expedia, Inc. v. Int’l Bus. Mach. Corp.,
`IPR2019-00404, Pap. 8 (June 5, 2019) ............................................................... 31
`Feit Elec. Co. v. Philips Lighting N. AM. Corp.,
`IPR2018-00790, Pap. 9 (Oct. 10, 2018) ............................................................. 55
`Fluidmaster, Inc. v. Danco, Inc.,
`IPR2017-00770, Pap. 13 (July 28, 2017) ........................................................... 39
`Free-Flow Packaging Int’l, Inc. v. Automated Packaging Sys., Inc.,
`IPR2016-00351, Pap. 7 (June 27, 2016) ............................................................. 51
`Front Row Techs., LLC v. MLB Adv. Media, L.P.,
`IPR2015-01932, Pap. 7 (March 25, 2016) ......................................................... 58
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Pap. 19 (Sept. 6, 2017) ............................................ 9, 20, 24, 29
`Graham v. John Deere,
`383 U.S. 1 (1996) ................................................................................................ 55
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 8
`Healthcare Logistics, Inc. v. Kit Check, Inc.,
`IPR2019-00385, Pap. 7 (June 3, 2019) ............................................................... 57
`Hologic, Inc. v. Enzo Life Scis. Inc.,
`IPR2018-00019, Pap. 21 (Nov. 28, 2018) .................................................... 32, 34
`Hulu, LLC v. Sound View Innovations, LLC,
`IPR2018-01039, Pap. 29 (Dec. 20, 2019) ..................................................... 48, 49
`
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`
`InfoBionic, Inc. v. Braemer Mfg., LLC,
`IPR2016-01236, Pap. 8 (Dec. 23, 2016) ............................................................. 50
`Instrumentation Lab. Co. v. Hemosonics, LLC,
`IPR2018-00264, Pap. 8 (May 10, 2018) ............................................................. 24
`Intel Corp. v. Inst. of Microelectronics, Chinese Academy of Scis.,
`IPR2019-00834, Pap. 11 (Oct. 4, 2019) ........................................... 12, 20, 21, 24
`Investors Exch., LLC. v. NASDAQ Tech. AB,
`IPR2018-01796, Pap. 11 (May 6, 2019) ............................................................. 45
`InVue Sec. Prods. Inc. v. Mobile Tech, Inc.,
`PGR2019-00019, Pap. 7 (May 29, 2019) ..................................................... 44, 52
`Ivantis, Inc. v. Glaukos Corp.,
`IPR2019-00972, Pap. 7 (Oct. 10, 2019) ........................................... 18, 19, 25, 28
`John Crane, Inc. v. Finalrod IP, LLC,
`IPR2016-01827, Pap. 6 (Jan. 31, 2017) .................................................. 50, 56, 57
`Juniper Networks, Inc. v. Parity Networks, LLC,
`IPR2018-01642, Pap. 11 (Apr. 10, 2019) ..................................................... 25, 27
`Laird Tech. Inc. v. A.K. Stamping Co.,
`IPR2018-01163, Pap. 8 (Dec. 18, 2018) ............................................................. 12
`Lifewave, Inc. v. Edward Blendermann,
`IPR2016-00571, Pap. 7 (Sep. 7, 2016) ............................................................... 39
`Linear Tech. Corp. v. In-Depth Test LLC,
`IPR2015-00421, Pap. 15 (July 21, 2015) ........................................................... 58
`In re Magnum Oil Tools, Int’l. Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 50
`Microsoft Corp. v. Biscotti, Inc.,
`878 F.3d 1052 (Fed. Cir. 2017) .......................................................................... 41
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .......................................................................... 42
`
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`
`
`NetApp Inc. v. Realtime Data LLC,
`IPR2017-01660, Pap. 17 (Jan. 25, 2018) ............................................................ 21
`Nichia Corp. v. Document Sec. Sys., Inc.,
`IPR2019-00398, Pap. 10 (Apr. 15, 2019) ........................................................... 21
`Nintendo Co. v. Genuine Enabling Tech LLC,
`IPR2018-00543, Pap. 7 (Aug. 6, 2018) .............................................................. 59
`Olympus Corp. v. Maxell, Ltd.,
`IPR2018-00905, Pap. 9 (Nov. 19, 2018) ............................................................ 23
`PayPal, Inc. v. IOENGINE, LLC,
`IPR2019-00884, Pap, 22 (Oct. 3, 2019) ................................................. 15, 16, 17
`Pfenex, Inc. v. Glaxosmithkline Biologicals SA,
`IPR2019-01478, Pap. 9 (Feb. 10, 2020) ....................................................... 25, 26
`Pharmacosmos A/S v. American Regent, Inc.,
`IPR2019-01142, Pap. 13 (Dec. 18, 2019) ..................................................... 26, 28
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................... 31, 35
`Robert Bosch LLC v. Orbital Australia PTY Ltd.,
`IPR2015-01249, Pap. 9 (Dec. 21, 2015) ............................................................. 34
`Roland Corp. v. inMusic Brands, Inc.
`IPR2018-00335, Pap. 14 (July 2, 2018) ....................................................... 40, 41
`Samsung Elecs. Am., Inc. v. Prisua Eng’g Corp.,
`948 F.3d 1342 (Fed. Cir. 2020) .......................................................................... 34
`Samsung Elecs. Co. v. ELM 3DS Innovations, LLC,
`IPR2017-01305, Pap. 11 (Oct. 17, 2017) ............................................... 13, 20, 23
`SAS Institute, Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ...................................................................................... 2, 6
`SharkNinja Operating LLC v. Flexible Techs., Inc.,
`IPR2018-00903, Pap. 8, (Oct. 17, 2018) ...................................................... 32, 33
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`Shenzen Silver Star Intelligent Tech. Co. Ltd. v. IrobotiRobot Corp.,
`IPR2018-00897, Pap. 9 (Oct. 1, 2018) ......................................................... 25, 28
`Shopkick Inc. v. Novitaz, Inc.,
`IPR2015-00279, Pap. 7(May 29, 2015) .............................................................. 58
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 60
`Symantec Corp. v. RPost Commc’ns Ltd.,
`IPR2014-00357, Pap. 14 (July 15, 2014) ........................................................... 42
`SynQor, Inc. v. Artesyn Techs., Inc.,
`709 F.3d 1365 (Fed. Cir. 2013) .......................................................................... 41
`TCL Corp. v. Telefonaktiebolaget LM Ericsson,
`IPR2015-01584, Pap. 74 (Jan. 24, 2017) ...................................................... 40, 41
`Teoxane S.A. v. Allergan, PLC,
`IPR2017-01906, Pap. 15 (March 9, 2018) .................................................... 50, 54
`TRW Auto. U.S. LLC v. Magna Elecs. Inc.,
`IPR2014-01347, Pap. 25 (Jan. 6, 2016) .............................................................. 49
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00062, Pap. 11 (Apr. 2, 2019) ......................................................passim
`Zetec, Inc. v. Westinghouse Elec. Co.,
`IPR2014-00384, Pap. 10 (Jul. 23, 2014) ............................................................ 53
`ZTE (USA) Inc. v. Fundamental Innovation Sys. Int’l LLC,
`IPR2018-01076, Pap. 14 (Dec. 3, 2018) ............................................................. 21
`STATUTES
`35 U.S.C. § 102 .................................................................................................. 34, 35
`35 U.S.C. § 103 ........................................................................................................ 35
`35 U.S.C. § 312(a) ................................................................................................... 55
`35 U.S.C. §312(a)(3) .................................................................................... 50, 52, 53
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`35 U.S.C. § 314 .................................................................................................passim
`35 U.S.C. § 314(a) ............................................................................................passim
`35 U.S.C. § 325(d) ............................................................................................... 1, 61
`REGULATIONS
`37 C.F.R. §42.100(b) ............................................................................................... 31
`37 C.F.R. § 42.104(b) .............................................................................................. 33
`37 C.F.R. § 42.104(b)(3) .................................................................................... 31, 32
`37 C.F.R. § 42.104(b)(4) .................................................................................... 31, 50
`37 C.F.R. § 42.104(b)(5) .......................................................................................... 50
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.108(a) ................................................................................................. 8
`37 C.F.R. § 42.108(c) ............................................................................................. 2, 4
`37 C.F.R. § 42.120 ..................................................................................................... 2
`37 C.F.R. § 42.122(b)… .......................................................................................... 26
`Changes to the Claim Construction Standard for Interpreting Claims
`in Trial Proceedings Before the Patent Trial and Appeal Board, 83
`Fed. Reg. 51,340, 51,342 (Oct. 11, 2018) .......................................................... 31
`MISCELLANEOUS
`Trial Practice Guide Update (July 2019), available at
`https://www.uspto.gov/ TrialPracticeGuide3 ..................................................... 28
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`Pursuant to 37 C.F.R. §42.107,2 Patent Owners3 Amgen Inc. and Amgen
`
`
`
`IPR2020-00314
`U.S. Patent 9,856,287
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`
`
`Manufacturing, Limited (collectively, “Patent Owner”) submit this Preliminary
`
`Response to the above-captioned Petition for Inter Partes Review (“Petition” or
`
`“Pet.” Pap. 4) of U.S. Patent No. 9,856,287 (the “’287 patent”), which is the third
`
`post-grant challenge filed against the ’287 patent, and the second the ’287 IPR
`
`Petitioners themselves have filed. Petitioners’ second IPR was filed after their
`
`first IPR was not instituted and Petitioners missed the deadline to file a Request
`
`for Rehearing, then subsequently sought to supplement their un-filed request. The
`
`present Petition should be denied in its entirety: pursuant to the Board’s discretion
`
`under §314; for Petitioners’ failure to take affirmative positions with respect to the
`
`correctness of, and failure to provide any analysis or record citations supporting,
`
`
`
` 2
`
` All emphasis/annotations added, and all statutory and regulatory citations are to
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`35 U.S.C. or 37 C.F.R., as the context indicates, unless otherwise stated.
`
`3 Petitioners here, apparently copying petitioners in PGR2019-00001, listed both
`
`Amgen Inc. and Amgen Manufacturing, Limited in the caption as “Patent Owner.”
`
`Amgen Manufacturing, Limited is an exclusive licensee. Nevertheless, consistent
`
`with the caption, this Preliminary Response refers collectively to both parties as
`
`“Patent Owner.”
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`1
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`

`

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`the constructions they identify; for Petitioners’ failure to address whether Claims 1,
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`
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`IPR2020-00314
`U.S. Patent 9,856,287
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`4–6, 8–10, 12, and 14–15 are indefinite (as asserted in PGR2019-00001); and for
`
`Petitioners’ failure to show a reasonable likelihood of prevailing on any asserted
`
`ground. Because of the procedural and substantive failings of the Petition,
`
`institution would not be in the interest of justice, or an efficient use of the Board’s
`
`limited time and resources. And, in light of SAS Institute, Inc. v. Iancu, 138 S. Ct.
`
`1348 (2018), even if Petitioners had made their threshold showing for some claims
`
`or grounds—they have not—the Board, in its discretion, should deny institution
`
`under §314(a) on all challenged claims and grounds in the Petition.
`
`I.
`
`Introduction
`Petitioners’ submission failed to provide the Board the basic evidence
`
`required to institute any inter partes review. If the Board nonetheless institutes
`
`trial on the Challenged Claims,4 Patent Owner will address in detail in its §42.120
`
`Response the numerous substantive errors and shortcomings in Petitioners’
`
`arguments and their purported evidence. Here, however, where testimonial
`
`evidence purporting to raise an issue of material fact “will be viewed in the light
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`most favorable to the petitioner” (§42.108(c)), Patent Owner addresses only a
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`
`
` 4
`
` Claims 1, 4–6, 8–10, 12, 14–16, 19–21, 23–26, 29–30 of the ’287 patent.
`
`2
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`

`

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`subset of the Petition’s procedural and substantive shortcomings. Because of these
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`IPR2020-00314
`U.S. Patent 9,856,287
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`threshold failures, the Petition should be denied and no IPR instituted under §314.
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`First, the present Petition (“IPR2,” “Pet.”) is a follow-on petition that should
`
`not be instituted under §314(a). See §III. Petitioners previously filed an IPR
`
`making the same substantive arguments to challenge the same claims of the ’287
`
`patent (IPR2019-00971, “IPR1”), and Petitioners knew of all the art in the present
`
`Petition from their first IPR, and much of the art from PGR2019-00001 (“PGR”),
`
`which was the first post-grant challenge filed against the ’287 patent. When they
`
`filed this obvious re-hash of their own prior petition, Petitioners had in hand, as
`
`improper road-maps to Patent Owner’s arguments, inter alia, Patent Owner’s
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`POPRs from the PGR and IPR1, Patent Owner’s POR from the PGR, and the
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`Board’s Institution Decisions from the PGR and IPR1.
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`Second, Petitioners failed to provide an analysis of the proper construction
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`of terms they were required to address, or to take an affirmative position as to the
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`constructions they identify. Instead—attempting to thwart the efficiency
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`motivations underlying the Board’s switch to the Phillips claim construction
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`standard in IPRs—Petitioners summarily asserted they “will assume” certain
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`constructions from the PGR while asserting they would do so “for purposes of this
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`IPR only.” Pet.24; see §IV. In so doing, Petitioners also provided no citations to
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`the record supporting the constructions they decided to “assume,” apparently (and
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`3
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`improperly) attempting to await some future litigation to reveal their real positions
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`regarding the proper constructions of the claims under Phillips.
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`Third, although indefiniteness was raised (and instituted) as a ground of
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`invalidity in the PGR (PGR ID (Pap. 13), 12–18, 22–26; EX2013 (PGR Pet. (Pap.
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`3)), 29–31) Petitioners here failed to take any position as to the definiteness of
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`Claims 1, 4–6, 8–10, 12, and 14–16, let alone provide any analysis setting forth
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`how or why the terms they seek to invalidate should be understood by the Board.
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`See §IV.
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`Fourth, Petitioners’ own arguments and evidence confirm they cannot make
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`a prima facie showing that, as a factual and legal matter for each asserted ground,
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`there is a reasonable likelihood of proving at least one Challenged Claim
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`unpatentable. See, e.g., §314; §42.108(c); §V. For example:
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`•
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`For Grounds 1 and 2, Petitioners failed to present any argument regarding
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`dependent claims requiring thiol-pair ratio and thiol-pair buffer strength to
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`be “calculated” (Claims 8, 9, 14, 15, 23, 24, 25, and 30) under their
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`identified construction, inexplicably relying on additional references in
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`asserting the limitations added by these dependent claims would have been
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`anticipated by Vallejo or Ruddon;
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`4
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`•
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`For Grounds 1 and 2, Petitioners failed to address how any of their
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`references disclose maintaining the solubility of the solution even under
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`Petitioners’ identified construction;
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`•
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`For Ground 1, Petitioners failed to address how Vallejo discloses
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`maintaining the solubility of the preparation when that term is properly
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`understood;
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`•
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`For Ground 2, Petitioners failed to address the fact that Ruddon’s process
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`does not result in a properly refolded protein, but results, instead, in a sub-
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`unit (hCG-β) that is competent to assemble with a second native (already-
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`folded) sub-unit (hCG-α) to form a biologically active protein (hCG);
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`•
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`For Grounds 3 and 4, Petitioners’ obviousness arguments are unclear,
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`confusing and legally insufficient. Petitioners, inter alia, (a) failed to
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`delineate clearly what grounds they actually assert, using an ambiguous
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`“and/or” approach that could reflect as many as four different grounds for
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`each of Grounds 4 and 5, (b) failed to clearly specify the references and
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`sections of the references Petitioners relied on for each combination, let
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`alone each given limitation, (c) failed to clearly identify the base reference
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`for each combination and how or why it was allegedly modified in the
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`proposed combination, (d) failed to provide any meaningful explanation for
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`5
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`reasonable expectation of success, and (e) failed to provide any argument
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`that any value was actually calculated for the claims that Petitioners
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`conceded require calculation.
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`In view of post-SAS all-or-nothing institution, even if, arguendo, the Board
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`were to unearth a Ground with merit buried within Petitioners’ pile of arguments
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`and combinations reflecting as many as five to ten different challenges per claim,5
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`the Board should exercise its discretion here and deny institution. Instituting this
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`proceeding would not be an efficient use of the Board’s limited time and resources
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`given Petitioners’ imprecise scattershot approach. See, e.g., SAS Inst. Inc. v. Iancu,
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`138 S. Ct. 1348, 1355–56 (2018); Everstar Merchandise Co. v. Willis Elec. Co.,
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`IPR2019-01484, Pap. 7, 36–38 (Feb. 20, 2020) (denying institution based on
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`inefficiency when only one-fifth of challenged claims warrant institution); Chevron
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`Oronite Co. v. Infieum USA LP, IPR2018-00923, Pap. 9, 9–11 (Nov. 7, 2018)
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`(informative) (denying institution on all claims when Petitioners’ arguments and
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` 5
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` As explained above, and in more detail below (infra, §V.C.1), because of
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`Petitioners’ inappropriate use of an “and/or” approach in identifying secondary
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`references for Grounds 3 and 4, each reflects as many as four different grounds per
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`“Ground.”
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`6
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`proofs were deficient with respect to a subset of claims); see also Deeper, UAB v.
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`U.S. Patent 9,856,287
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`Vexilar, Inc., IPR2018-01310, Pap. 7, 41–43 (Jan. 24, 2019) (informative)
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`(denying institution because “instituting a trial with respect to all twenty-three
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`claims and on all four grounds based on evidence and arguments directed to only
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`two claims and one ground would not be an efficient use of the Board’s time and
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`resources.”); SAS Q&As, D3, at p. 8 (USPTO June 5, 2018), available at
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`https://www.uspto.gov/sites/default/files/documents/
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`sas_qas_20180605.pdf (noting that, although “[t]he Board does not contemplate a
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`fixed threshold for a sufficient number of challenges for which it will institute,” it
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`will “evaluate the challenges and determine whether, in the interests of efficient
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`administration of the Office and integrity of the patent system ... the entire petition
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`should be denied under 35 U.S.C. § 314(a).”).
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`For these reasons, the Petition should be denied.
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`II. The Challenged Claims Of The ’287 Are Directed To A Novel Invention
`The ’287 is directed to a novel and efficient protein refolding method based
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`on control of redox conditions with reductant and oxidant (“redox”) reagents.
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`EX1001, 2:62–3:4. The goal of protein refolding is to increase and maximize yield
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`of properly-folded proteins. EX1001, 1:32–38. Desired proteins are
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`recombinantly expressed in non-mammalian culture systems (e.g., bacteria). But,
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`these expressed proteins misfold and precipitate in intracellular limited-solubility
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`7
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`precipitates known as inclusion bodies. Id., 1:25–30. These inclusion bodies are
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`formed because the bacterial host cell is unable to fold recombinant proteins
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`properly. Id., 1:29–31. The host cells are collected and lysed, and then the
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`released inclusion bodies are solubilized in a denaturing so